Registry for optimal treatment options for mitral valve issues
Choice of Optimal Transcatheter Treatment for Mitral Insufficiency Registry
Universitätsklinikum Hamburg-Eppendorf · NCT04688190
This study looks at how well different treatments work for people with serious mitral valve problems, comparing those who had a new valve implanted to those who weren't able to get that treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Universitätsklinikum Hamburg-Eppendorf (other) |
| Locations | 43 sites (Tucson, Arizona and 42 other locations) |
| Trial ID | NCT04688190 on ClinicalTrials.gov |
What this trial studies
This multinational observational study investigates the outcomes of patients with clinically significant mitral insufficiency who underwent transcatheter mitral valve implantation (TMVI) compared to those who were screened for TMVI but deemed ineligible. The study collects and analyzes echocardiography data at baseline and after various interventions, including edge-to-edge repair and surgical options. By examining these outcomes, the study aims to provide insights into the effectiveness of different treatment approaches for mitral regurgitation.
Who should consider this trial
Good fit: Ideal candidates for this study are adults with clinically significant mitral insufficiency who have been screened for TMVI.
Not a fit: Patients under 18 years of age will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help identify the most effective treatment options for patients with mitral regurgitation, leading to improved patient outcomes.
How similar studies have performed: Other studies have shown success with similar observational approaches in evaluating treatment outcomes for heart conditions, suggesting this methodology is promising.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * clinically significant mitral insufficiency * patient underwent screening for TMVI * echocardiography data at baseline (and after TMVI, E2E and surgery) * follow-up of at least 30 days Exclusion Criteria: \- age under 18 years
Where this trial is running
Tucson, Arizona and 42 other locations
- Tucson Medical Center — Tucson, Arizona, United States (RECRUITING)
- Cedars-Sinai Medical Center, Los Angeles — Los Angeles, California, United States (RECRUITING)
- Tampa General Hospital — Tampa, Florida, United States (RECRUITING)
- Brigham and Women's Hospital — Boston, Massachusetts, United States (RECRUITING)
- Minneapolis Heart Institute at Abbott Northwestern Hospital — Minneapolis, Minnesota, United States (RECRUITING)
- Morristown Medical Center — Morristown, New Jersey, United States (RECRUITING)
- Montefiore Medical Center — New York, New York, United States (RECRUITING)
- Oklahoma Heart Hospital — Oklahoma City, Oklahoma, United States (RECRUITING)
- Houston Methodist Hospital — Houston, Texas, United States (RECRUITING)
- St Vincent's Hospital — Sydney, Australia (RECRUITING)
- Medical University of Vienna — Vienna, Austria (RECRUITING)
- Québec Heart and Lung Institute (Laval University) — Québec, Quebec, Canada (RECRUITING)
- Toronto Heart Center — Toronto, Canada (RECRUITING)
- St. Paul's Hospital — Vancouver, Canada (RECRUITING)
- Rigshospitalet — Copenhagen, Denmark (RECRUITING)
- CHU Bordeaux — Bourdeaux, France (RECRUITING)
- Lille University Hospital — Lille, France (RECRUITING)
- Civils Hospices of Lyon — Lyon, France (RECRUITING)
- Clinique Pasteur — Toulouse, France (RECRUITING)
- HDZ Bad Oeynhausen — Bad Oeynhausen, Germany (RECRUITING)
- German Heart Center Berlin — Berlin, Germany (RECRUITING)
- Heart Center Bonn — Bonn, Germany (RECRUITING)
- University Hospital of Cologne — Cologne, Germany (RECRUITING)
- Goethe-Universität - University Hospital Frankfurt — Frankfurt, Germany (RECRUITING)
- University Heart and Vascular Center Hamburg — Hamburg, Germany (RECRUITING)
- University Heart Center Lübeck — Lübeck, Germany (RECRUITING)
- Heart Center of the University Medical Center Mainz — Mainz, Germany (RECRUITING)
- German Heart Centre Munich — Munich, Germany (RECRUITING)
- LMU Munich — Munich, Germany (RECRUITING)
- University Medical Center Ulm — Ulm, Germany (RECRUITING)
- Interbalkan Medical Center — Thessaloniki, Greece (RECRUITING)
- ASST Spedali Civili di Brescia — Brescia, Italy (RECRUITING)
- San Raffaele University Hospital — Milan, Italy (RECRUITING)
- IRCCS Humanitas Research Hospital — Milan, Italy (RECRUITING)
- IRCCS Policlinico San Donato — Milan, Italy (RECRUITING)
- University Hospital of Pisa — Pisa, Italy (RECRUITING)
- Rikshospitalet, Oslo University Hospital (OUS) — Oslo, Norway (RECRUITING)
- Poznan University of Medical Sciences — Poznan, Poland (RECRUITING)
- Warsaw Medicover Hospital — Warsaw, Poland (RECRUITING)
- Inselspital Bern — Bern, Switzerland (RECRUITING)
- USZ Zurich — Zurich, Switzerland (RECRUITING)
- Royal Brompton Hospital — London, United Kingdom (RECRUITING)
- St Thomas' Hospital - London — London, United Kingdom (RECRUITING)
Study contacts
- Principal investigator: Lenard Conradi, MD — University of Cologne
- Study coordinator: Sebastian Ludwig, MD
- Email: se.ludwig@uke.de
- Phone: +494074100
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Mitral Regurgitation, Mitral Valve Disease, Mitral Annular Calcification